FDA Guidance on Real-World Evidence

Dr. John Concato, from the Office of Medical Policy in FDA’s Center for Drug Evaluation and Research, will discuss “FDA Guidance on Real-World Evidence.” His presentation will describe the main components of FDA’s Real-World Evidence Program, focusing on guidance development. Dr. Concato will also summarize the historical context leading to the current focus on real-world evidence, and he will identify challenges when using real-world data and real-world evidence in drug development. A question-and-answer period will follow.

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